Randomized Trial of Immediate Treatment vs. Colposcopic Follow-up for Biopsy-Proven CIN 1
Inclusion Criteria:
- Eligible patients will:
- have documented CIN 1 by histologic assessment as the highest grade lesion
present,
- have the lesion confined to the cervix and completely visualized,
- be 16 years or older.
Exclusion Criteria:
- any one of the following will be an excluding characteristic:
- index Pap smear showing CIN 2, CIN 3 or cancer;
- index Pap smear shows atypical glandular cells of unknown significance,
glandular dysplasia, or malignancy requiring immediate investigation;
- patients with previously identified CIN 1 by biopsy who are already in a
colposcopic surveillance program;
- unsatisfactory colposcopic exam defined as inability to see the extent of the
lesion in the endocervical canal or absence of a lesion on the ectocervix but
endocervical curettage shows CIN 1;
- pregnancy;
- prior therapy for dysplasia including medical (5FU), surgical (Laser, LEEP) or
cryotherapy;
- prior gynecologic cancer;
- prior pelvic radiation therapy;
- inability to attend outpatient follow-up visits because of geographic
inaccessibility;
- other malignancies except non-melanoma skin cancer;
- immunosuppression due to diseases such as AIDS, organ transplantation, or on
immunosuppressive medications such as prednisone, imuran or chemotherapy for
diseases like systemic lupus;
- cognitively impaired or otherwise unable to obtain written informed consent;
- extension of the CIN 1 lesion to vagina or a separate vaginal lesion showing
dysplasia;
- colposcopically visible condyloma outside of the transformation zone;
- known allergy to local analgesics;
- clinically evident vaginitis must be treated and resolved prior to entry on the
trial;
- inability to read and respond in English/French;
- failure to provide informed consent.